BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury (BEFAST)

BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury in Hemodynamically Stable Blunt Abdominal Trauma

The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly enhance the evaluation of the trauma patient with acute intra-abdominal injury through the use of intravascular microbubbles that allow direct visualization of lacerations to solid organs. European studies have demonstrated that ultrasound contrast markedly improves the sensitivity of ultrasound in detecting solid organ injury, when the exam is performed in the radiology suite. The researchers hypothesize that the bubble-enhanced FAST or BEFAST exam will be more sensitive than traditional FAST for identification of solid organ injury in hemodynamically stable blunt abdominal trauma patients when performed by emergency providers.

Study Overview

• Status: Completed
• Conditions: Abdominal Trauma
• Intervention / Treatment: Diagnostic test: Focused Assessment with Sonography for Trauma (FAST); Drug: Bubble-Enhanced FAST (BEFAST)

Detailed Description

Blunt abdominal trauma, whether from motor vehicle crash, assault, fall, or recreational injury, is a leading cause of morbidity and mortality. According to the 2016 National Trauma Database, 12% of all patients with trauma admissions had abdominal trauma, the majority of which is blunt. The diagnosis of intra-abdominal injury due to blunt abdominal trauma can be challenging. The physical exam is unreliable in patients with altered mental status or with impairment due to drugs or alcohol. While computed tomography (CT) can rapidly and accurately diagnose injury, emergency physicians have raised concerns that the use of CT has become overly liberal. The risks of overutilization of CT in hemodynamically stable blunt abdominal trauma include increased health care costs, lengthy stays in the emergency department, risks of contrast-induced nephropathy and radiation-induced malignancy, and patient anxiety when "incidentalomas" are discovered that need extensive and often unnecessary workup.

The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of the advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly enhance the evaluation of the trauma patient with acute intra-abdominal injury through the use of intravascular microbubbles that allow direct visualization of lacerations to solid organs.

In 2016, the Food and Drug Administration (FDA) approved Lumason (sulfur hexafluoride lipid-type A microsphere) for characterization of focal liver lesions with CEUS in both adult and pediatric patients, opening new areas of research in the United States. Lumason is a second generation contrast agent that is more stable than previous ultrasound contrast agents and does not require refrigeration. Although approved for intravascular and intravesical use, Lumason's use in a trauma exam is off-label in the United States.

After participants provide informed consent, a baseline FAST exam will be performed and documented. This exam will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. If not already placed, an intravenous line will be established according to standard practice for trauma patients. Following the FAST exam, a bubble-enhanced FAST (BEFAST) exam will be performed using Lumason as the contrast agent. As part of the standard of care, participants will have a CT exam performed within 24 hours, which will provide the gold standard for diagnosis of solid organ trauma.

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical suspicion of intra-abdominal injury
• Presentation within 24 hours of injury
• Planned CT of the abdomen/pelvis within 24 hours
• Ability of patient or legally authorized representative to provide informed consent

Exclusion Criteria:

• Co-existing penetrating abdominal injury
• Known hypersensitivity reaction to contrast agent
• Pregnant patients
• Prisoners
• No appropriate IV Line able to be inserted
• Hemodynamic instability at time of enrollment (sustained systolic blood pressure < 90 mm Hg or sustained heart rate (HR) >120 despite initial resuscitation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Non-enhanced FAST exam followed by BEFAST exam; Participants in the emergency department with hemodynamically stable blunt abdominal trauma will receive the standard of care Focused Assessment with Sonography for Trauma (FAST) exam followed by a Bubble-Enhanced FAST exam.

Diagnostic test: Focused Assessment with Sonography for Trauma (FAST); The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of Advanced Trauma Life Support (ATLS) protocol. After consent, a baseline FAST exam will be performed and documented. This FAST will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. The investigator will use a phased array or curvilinear transducer to record video of their baseline FAST exam.; Drug: Bubble-Enhanced FAST (BEFAST); Following the FAST exam and using the same machine, a BEFAST exam will be performed using a low mechanical index setting in contrast-specific imaging mode. A 2.4 mL IV dose of Lumason will be injected into the subject's IV, followed by saline flush. The contrast will be injected once for the right side of the body, and once for the left side of the body looking for disruptions in the normal enhancement pattern and evidence of active bleeding. To examine the right side of the body: the liver will be imaged first in arterial phase, followed by the right kidney, before returning to image the liver in venous phase. To examine the left side of the body: the pancreas will be imaged first, followed by the kidney and the spleen. The investigator will note evidence of solid organ injury, free fluid, or active extravasation on both sides of the body; lacerations will be graded by the American Association for the Surgery of Trauma (AAST) criteria.; Other Names: Lumason

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives	The performance of the study exams will be assessed as the number of correctly identified solid organ injuries (true positives) detected by FAST exam and BEFAST exam. The presence of injury will be determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.	1 Day of exam
Specificity of Detecting Solid Organ Injury Measured as the Number of True Negatives	The performance of the study exams is assessed as the percentage of correctly identified lack of solid organ injuries (true negatives) detected by FAST and BEFAST exams. The presence of solid organ injury is determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.	1 Day of exam
Number of Enrolled Participants With Successful Exams	The number of successful, completed exams is used to determine whether emergency physicians can incorporate BEFAST evaluation at the point-of-care. The exam is considered complete if the participant tolerates the study without experiencing severe adverse events to contrast and the participant allows the provider to complete the scan, and if the exam results in images of adequate quality to answer the focused clinical question.	1 Day of exam
Percent Agreement Between Raters	Emergency physicians' interpretations of the ultrasound exams are compared to interpretations of board-certified radiologists for the presence or absence of solid organ injury, free fluid, or active extravasation. Injured organs are graded per American Association for the Surgery of Trauma (AAST) criteria.	1 Day of exam

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Laura Oh, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound contrast; Solid organ injury; Blunt abdominal trauma
• Additional Relevant MeSH Terms: Wounds and Injuries; Abdominal Injuries
• Other Study ID Numbers: IRB00100619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data collected during the trial will be made available for sharing, after de-identification.
• IPD Sharing Time Frame: Data will be made available for sharing beginning 9 months after study publication and ending 36 months after article publication.
• IPD Sharing Access Criteria: Individual participant data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the approved proposal. Proposals should be directed to laura.oh@emory.edu. To gain access, data requestors will need to sign a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No